Encore
Manual vacuum erection device and battery vacuum erection device
10manufacturers in China registered for this device type
39catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (2), Hong Kong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Armocon Technology Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 5 |
| Odeco Ltd. | Baoan District, Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shenzhen S-Hande Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangzhou Zhongshu E-Commerce Co., Ltd. | Guangzhou | Guangdong | Exporter | 7 |
| Shenzhen Canwin Health Products Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Dongguan Dingfoo Plastic Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 5 |
| Junrong Jiaye (Dongguan) Technology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
| Dolanvy (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| D-PUB Electronic & Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 3 |
| Daka International Limited | Kowloon | Hong Kong | Exporter | 2 |
Record
| Listed by | Encore, Inc., United States |
|---|---|
| FDA product code | LKY |
| Device type | Device, External Penile Rigidity |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5020 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-07-25 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10 INCH AMERICAN TUBE | In distribution | |
| 44017 UNB – Carton 12 | In distribution | |
| INSPECTED MANUAL PUMP | In distribution | |
| BODYSHIELD | In distribution | |
| 20/Master | In distribution | |
| SILICONE RING #9 | In distribution | |
| Deluxe System – 12 pack of devices | In distribution | |
| SILICONE RING #7 | In distribution | |
| SILICONE RING #3 | In distribution | |
| SILICONE RING #8 | In distribution | |
| VA VTU-E | In distribution | |
| 44017 UNM – Carton 12 | In distribution | |
| 44017 RETNP – 3 kits | In distribution | |
| INSPECTED BLACK BTRY PUMP | In distribution | |
| 12/Master | In distribution | |
| SILICONE RING #6 | In distribution | |
| ACRYLIC RING EJECTOR | In distribution | |
| SILICONE RING #4 | In distribution | |
| Manual 12/Master | In distribution | |
| Battery System for the VA – 12 pack of devices | In distribution | |
| SILICONE RING #5 | In distribution | |
| Deluxe VTU-E | In distribution | |
| Premium System | In distribution | |
| 20/Master | In distribution | |
| VA VTU-1 | In distribution | |
| INSPECTED PREMIUM MANUAL PUMP U.S. | In distribution | |
| 44017 UNM – 3 kits | In distribution | |
| Manual System for the VA – 12 pack of devices | In distribution | |
| Erect Pro Plus Manual and Battery | In distribution | |
| Premium System – Case of 12 device | In distribution | |
| 44017 UNB – 3 kits | In distribution | |
| Battery 12/Master | In distribution | |
| AMERICAN CONE | In distribution | |
| AMERICAN PENILE TUBE | In distribution | |
| 50/Master | In distribution | |
| Erect Pro Manual | In distribution | |
| Erect Pro Battery | In distribution | |
| 44017 RETNP – Carton 12 | In distribution | |
| VTU-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Performance | Blush Novelties | 53 |
| Bathmate | DX Products Limited | 41 |
| Stay Hard | Blush Novelties | 37 |
| Timm Medical | POS-T-VAC, LLC | 32 |
| Pos-T-Vac | POS-T-VAC, LLC | 31 |
| Play With Me | Blush Novelties | 19 |
| Gesiva Medical | Gesiva Medical LLC | 12 |
| Performance Plus | Blush Novelties | 12 |
| Dr. Joel Kaplan | DR Joel Kaplan Inc | 9 |
| Eddie | Giddy Holdings, Inc. | 8 |
| Vaxaid | DX Products Limited | 7 |
| Rapport | Owen Mumford USA, Inc. | 7 |
Showing 12 of 106. All products under Device, External Penile Rigidity
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K974470 | 1998-01-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.